human stem cell derived neuron

3D-Prediction of Patient-Specific Response (3D-PREDICT)

Summary

This observational study will evaluate an assay using a patient’s own biopsy or resected tumor tissue to assess tissue response to various therapeutic agents. This patient-specific assay is an ex vivo drug response assay (EV3D) using samples from patients with advanced cancers, including high-grade gliomas (HGG) like anaplastic astrocytoma and glioblastoma

Tumor tissue will be collected from participants undergoing surgery or biopsy to remove suspected, newly diagnosed, or recurrent HGG. Other eligible cancers include epithelial ovarian cancer and high-grade rare tumors. The collected samples from all eligible participants will be tested with the EV3D Assay to assess tissue response to standard of care agents. 

This observational study will evaluate the EV3D Assay, by comparing assay results to patient outcomes and determining the assay's potential for predicting treatment response and impacting medical decision-making. 

 

Inclusion Criteria
  1. Patient 18 years and older
  2. Any patient with a diagnosis of or a suspected diagnosis of advanced cancer (ovarian, brain or other rare tumors) undergoing surgery or biopsy to remove tumor tissue
  3. Must be considered a candidate for systemic therapy with cytotoxic chemotherapy, targeted small molecule inhibitors or immunotherapy
  4. Must have an Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2
  5. Written informed consent in accordance with institutional standards must be obtained from patient or legal guardian

For the most up-to-date list of criteria, please visit clinicaltrials.gov.

Exclusion Criteria
  1. Patient refusing or unable to sign informed consent
  2. Patient who fails to have surgery or a biopsy as part of routine clinical practice
  3. Patient who refuses to have the Assay performed on their tissue
  4. Known active cancer metastatic to the brain except for patients with brain metastases that have been treated and are stable.
  5. Patients unable or unwilling to receive treatment beyond surgery
  6. Any coincidental medical condition that, in the investigator's opinion would preclude participation in the study or compromise the patient's ability to give informed consent
     

For the most up-to-date list of criteria, please visit clinicaltrials.gov.

Investigator(s)

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